Dietary intervention to improve heart health in older people with HIV
Effectiveness of Gut Microbiota-targeted Diatery Intervention in Preventing Atherosclerotic Cardiovascular Disease Among Older People Living With HIV
This study is testing whether a special diet can help older people with HIV improve their heart health and lower their risk of heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shenzhen) |
| Trial ID | NCT06560840 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a gut microbiota-targeted dietary intervention for preventing atherosclerotic cardiovascular disease (ASCVD) among older individuals living with HIV. Utilizing a pragmatic randomized controlled trial design, participants will be randomly assigned to either an intervention group receiving dietary guidance or a control group continuing standard health education. The intervention will last for three months, with follow-up assessments at three and six months to measure ASCVD risk and gut microbiota changes. The study is conducted at Shenzhen Third People's Hospital, focusing on real-world applicability of the findings.
Who should consider this trial
Good fit: Ideal candidates are HIV-infected individuals aged 40 and above who are at risk for cardiovascular disease.
Not a fit: Patients with a history of cardiovascular disease or serious cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of cardiovascular disease in older patients living with HIV.
How similar studies have performed: While dietary interventions have been explored in various contexts, this specific approach targeting gut microbiota in older HIV patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. HIV-infected patients diagnosed according to the diagnostic criteria of China AIDS diagnosis and treatment guidelines; 2. Aged 40 years and above; 3. at risk of CVD: having any two of those risk factors: dyslipidemia, DM or elevated blood glucose, smoking, hypertention or elevated blood pressure, metabolic syndrome,overweight/obesity; or PCE score\>5%, 4. Those with a predicted survival time of \>1 year; 5. No plans to leave the depth in the next 3 months; 6. Voluntary participation in this study and signing the informed consent Exclusion Criteria: 1. Those with a previous history of CVD; 2. Those with HIV-related neurocognitive impairment, Alzheimer's disease or dementia, and a variety of serious opportunistic infections; 3. Currently suffering from malignant tumors, gastrointestinal diseases; People with an aversion to eating; 4. Allergic to nuts and fish; 5. People who take medicinal calcium \>1000 mg per day or omega-3 supplements; 6. Plan to become pregnant within 6 months; 7. Are participating in other HIV-related or dietary intervention-related scientific research programs.
Where this trial is running
Shenzhen
- The Third People's Hospital of Shenzhen — Shenzhen, China (Recruiting)
Study contacts
- Study coordinator: Junwen Yu, Dr
- Email: 13320178333@163.com
- Phone: 13320178333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.